NIH-funded research R01 grant

Hydrogen therapy for newborns with brain injury

Official title: Hydrogen in neonatal encephalopathy (HIE) Trial

Funded at Boston Children's Hospital · NIH-11341428 · Data updated 2026-11-12

A new NICU trial will test inhaled hydrogen added to standard hypothermia therapy to see if it can improve survival and brain outcomes for babies with hypoxic-ischemic brain injury.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionBoston Children's Hospital
NIH-funded
Lab location1 site (Boston, United States)
Project startAugust 14, 2026
Project endJuly 31, 2030
Funding year2026
Award (this year)$3,424,232
NIH project number1R01HD121633-01
Project IDNIH-11341428 on NIH RePORTER

Who could benefit from this research

Could help

Term neonates with moderate to severe hypoxic-ischemic encephalopathy treated in the NICU alongside standard hypothermia therapy.

Less likely to help

Premature infants, or those not eligible for hypothermia treatment, may not benefit from this specific approach.

What this research studies

This project tests whether giving a small amount of inhaled hydrogen together with standard cooling therapy in term newborns with moderate to severe brain injury from HIE can be safe and feasible in the NICU. Researchers will use MRI to measure acute brain injury and will follow infants to age two to explore neurodevelopmental outcomes. The study builds on promising preclinical and early clinical data and will be conducted at Boston Children’s Hospital. If successful, it could offer a new adjunct treatment to reduce death and disability in affected infants.

Why it matters

Potential benefit: If hydrogen is safe and beneficial, it could become an additional therapy alongside cooling to improve brain recovery and long-term development in newborns with HIE.

How similar studies have gone: Preclinical work and early human data hint at safety and potential benefit, but large randomized neonatal trials are still needed.

Where this research is happening

  • Boston Children's Hospital
    Boston, United States
    Active

Researchers

  • Principal investigator: Kalish, Brian — Boston Children's Hospital
  • Study coordinator: Kalish, Brian

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.